The European Medicines Agency's (EMA) human medicines committee (CHMP) recommended using Pfizer Inc PFE - BioNTech SE's BNTX's COVID-19 vaccine, Comirnaty, for children between 5 to 11.
- Pfizer-BioNTech's vaccine will be given in two 10-microgram doses three weeks apart as an injection in the upper arm, per the EMA recommendation.
- Adult doses of the vaccine contain 30 micrograms.
- Pfizer / BioNTech's vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.
- "The benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19," the EMA said.
- While final approval is up to the European Commission, an EU source told Reuters that a decision would likely come on Friday.
- "Today's recommendation (...) is clear the BioNTech-Pfizer vaccine is safe and effective for young children and can offer them additional protection," EU health commissioner Stella Kyriakides said on Twitter.
- Related Link: Pfizer, BioNTech Seek FDA Approval For COVID-19 Vaccine In Kids Aged 5-11: Reuters.
- The companies expect initial data from an ongoing trial in younger children aged 2-5 years in Q4 and kids aged six months to 2 years in Q1 of 2022, with full data readouts to follow.
- Price Action: PFE shares are up 5.52% at $53.7, BNTX shares are up 7.30% at $327 during the premarket session on the last check Friday.
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